Approximately 2.5 million laparoscopic surgeries are performed each year in the U.S and more than 5 million worldwide. Laparoscopic surgeries insert a device known as a trocar through body tissue, such as the abdominal wall. A trocar consists of two pieces: a central obturator, which comprises a handle and a puncturing tip; and a cannula, which is typically tube-shaped. Once through the abdominal wall the obturator is removed from the cannula and the cannula is left in place, traversing the abdominal wall. The cannula serves as a port that facilitates surgical instruments, endoscopes, and the like, which allow the surgery to be performed inside the abdomen or other body cavity through small incisions in the abdominal wall (FIG. 1). Trocars are typically 5-15 mm in diameter and most surgeries use at least three, including one that is 10 mm or larger to accommodate larger instruments and specimen removal. The wounds left by the larger trocars require closure of the intra-abdominal port to prevent intestinal herniation through the defect in the abdominal wall.
Current methods for closing these larger port sites are either difficult to perform or are cumbersome, can require considerable time to execute, and may place the surgeon at risk for needle sticks. The current “standard of care” for the closure of intra-abdominal defects is performed using a needle attached to suture material and guided through the trasversalis fascia with needle-nosed forceps. Ineffective closure of intra-abdominal defects increases the patient's risk to herniation at the closure site. The consequences of intestinal herniation through a laparoscopic port can be severe, including organ necrosis and intestinal loop rescission.
Additionally, patients with thick abdominal walls increase the difficulty, time, and risk for proper port closure. This often results in misplaced suture and ineffective closure of the port. In 2011, the NIH published a study reporting that patients suffered from trocar site herniation 1.85% of the time on average. The results were highly dependent on surgical technique and complication rates ranged from 0.07% to 22%. Accordingly, there is a need for a consistent method for port closure following laparoscopic surgery.
Several devices have been set forth to address this need, such as U.S. Pat. No. 8,109,943, to Boriah. Boriah discloses a trocar with a specially-adapted cannula shaft, and a obturator, also variously defined as a shaft or port element, which works in conjunction with the cannula to insert suture anchors through the fascia wall. A major drawback to such a device is that the specially-adapted cannula is thicker due to needles and the like contained within, and it must be used. This is problematic, especially if a practitioner wishes to use a cannula with different features, such as thinner walls, lights, irrigation or aspiration mechanisms, or different markings. Further, the specially-adapted cannula must either be left in place during surgery, or the surgery must be performed, the original cannula withdrawn, and then the specially-adapted cannula-obturator inserted in order to close the port—a process resulting in further tissue damage. Because of the complexity of such devices, they are also more expensive to manufacture.
Accordingly, there is a need for a port closure device which is simple, which can be used in conjunction with any type of suitably-sized cannulae, and which is both easy to use and inexpensive to manufacture.